Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at EH Cardiovascular Institute of Palm Beach on 06/08/2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration verification records and interview, the laboratory failed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- to perform calibration verification every 6 months on the Abbott iStat analyzer from 08/11/2021 to 06/08/2023. Findings Included: Review of calibration verification records for the Abbott iStat revealed the calibration verification for activated clotting time, pH, partial pressure carbon dioxide (pCO2), partial pressure oxygen(pO2), base excess, bicarbonate (HCO3), total carbon dioxide (tCO2), sulfur dioxide (sO2), sodium, potassium, hemoglobin,and hematocrit, had not been performed since the initial survey conducted 08/11/2021 to the date of the current survey (06/08/2021). Record review of the laboratory's procedure titled "Calibration and Quality Control" signed and dated by the laboratory director on 02/02/2021, revealed "Criteria for Frequency of Calibration and Calibration Verification... 5. At least every 6 months." On 06/08/23 at 11:55 AM, the Technical Consultant confirmed that the every 6 months calibration verification had not been performed on the analyzer. -- 2 of 2 --